ANDA 77436, held by Apotex. Flunisolide.
As of Nov 14, 2026, ANDA 77436 (Flunisolide), held by Apotex, was first approved by FDA on Aug 9, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 9, 2007 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Flunisolide0.029MG/SPRAY ยท spray, metered;nasal | Flunisolide | Discontinued |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
